The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction

University Hospital Hradec Kralove

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Procedure: Restrictive group; Procedure: Liberal group

Study type: Interventional

Funder types: Other

Identifiers

NCT02536885

201508-S21P

Details and patient eligibility

About

Permanent and temporary cognitive impairment in the perioperative period is of great importance to patients. Hypoperfusion due to the intraoperative hypotension is often mentioned as a possible cause of postoperative cognitive dysfunction.

Full description

All patients aged above 60 years undergoing planned spinal surgery in the prone position in the duration of 1-3 hours under general anesthesia will be included in the study. In group L (liberal), the value of blood pressure will be corrected with the change of mean arterial pressure (MAP) ± 25% patient's mean arterial pressure, and group R (restrictive) with the change of MAP ± 10%. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophyllin, nor pharmacological decurarization (syntostigmin) will be applied to the patients.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• GCS 15
• ASA risk I - III
• planned spinal surgery in the prone position
• duration of the procedure of 1-3 hours

Exclusion criteria

• hypertension above 180/100 torr preoperatively
• blood pressure below 130/80 torr preoperatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Liberal group

Experimental group

Description:

During the surgery, blood pressure of the patients will be maintained within ± 25% of the patient's normal blood pressure.

Treatment:

Procedure: Liberal group

Restrictive group

Experimental group

Description:

During the surgery, blood pressure of the patients will be maintained within ± 10% of the patient's normal blood pressure.

Treatment:

Procedure: Restrictive group